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IRCT20230310057672N6 IRCT 2025-01-29 University of Baghdad/College of Nursing Effect of Virtual Reality and Shot Blocker for Managing Pain, Anxiety, and Vital Signs A Comparative Study of Virtual Reality and Shot Blocker Maneuver for Managing Pain, Anxiety, and Vital Signs in Patients During Bone Marrow Aspiration and Biopsy: Randomized Controlled Trail 2025-02-06 anticipated 223 Complete https://irct.ir/trial/80182 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Supportive, Randomization description: Simple randomization by using four cards blue, red, green, yellow put in the box the blue card represented virtual reality (A group), red card for shot blocker (B group), green card for virtual reality and shot blocker together (AB group), and yellow card for control (C group). Then all participant was allowed to choose one of these cards. No allocation concealment will be carried out. N/A Condition 1: Pain. Condition 2: Anxiety. Condition 3: Changes in vital signs. Condition 4: Vital signs: heart rate. Condition 5: Vital signs: Heart rate. Condition 6: Vital signs: Breathing rate. Intervention 1: Intervention group (A): virtual reality (VR) technology only, this group received virtual reality technology using Samsung gear VR The patient is placed in the prone position and the virtual reality goggles are placed on the patient's head before the bone marrow aspiration and biopsy procedure begins, where a video containing natural scenes is shown through the VR glosses and calm music. After the procedure is completed, the patient's pain are measure by visual analog scale, anxiety are measure by stat-trait anxiety scale (STAS) The 20-item SAI and vital signs are measure by portable monitor device. Intervention 2: Intervention group (B): The ShotBlocker is a diminutive, flat, U-shaped plastic apparatus adorned with rounded protuberances. It is applied to the skin during the administration of injections and operates by stimulating the nerve endings situated around the injection site. This tactile stimulation is posited to alleviate pain by temporarily obstructing the conveyance of pain signals to the central nervous system. ShotBlocker put on site of needle insertion of bone marrow aspiration device. After the procedure is completed, the patient's pain are measure by visual analog scale, anxiety are measure by stat-trait anxiety scale (STAS) The 20-item SAI and vital signs are measure by portable monitor device. Intervention 3: Intervention group (AB): virtual reality technology and ShotBlocker maneuver use during procedure and After the procedure is completed, the patient's pain are measure by visual analog scale, anxiety are measure by stat-trait anxiety scale (STAS) The 20-item SAI and vital signs are measure by portable monitor device. Intervention 4: Control group (C): Subjects in the control group with bone marrow aspiration and biopsy. No intervention was provided during the study. . After the procedure is completed, the patient's pain are measure by visual analog scale, anxiety are measure by stat-trait anxiety scale (STAS) The 20-item SAI and vital signs are measure by portable monitor device. Yes - There is a plan to make this available What will be shared: The data will be results of comparing the effect between intervention and control groups using reliable measures. When: God willing, once finishing the process of data collection, analysis, and successful publishing of the manuscript, all the related files will become available for five months after the publications, after you are approved to register on the Iranian clinical trials website To whom: All the related files will be shared with any scientific interested parties. Conditions: It may be used after seeking the author's permission and acknowledging his contribution Where to obtain: The author's professional e-mail that will be available with the published manuscript can be used to contact the author. e-Mail: alaaj@conursing.uobaghdad.edu.iq How to obtain: The processes involved in accessing this documentation are possible via email: alaaj@conursing.uobaghdad.edu.iq, the first and last name of authors, trial' title variable and the trial Id. Comments: Profound appreciations are due to the IRCT members for their genuine efforts in helping researchers fulfilling their academic endeavors. The four groups were added individually in each field. We hope that the modifications will be appropriate to the design of the experiment. With many thanks and appreciation for your patience.
public Alaa Jawad Kadhim
Baghdad, Street 729
Baghdad Iraq 10045 +964 770 352 0314 alaaj@conursing.uobaghdad.edu.iq University of Baghdad/college of Nursing scientific Alaa Jawad Kadhim
Baghdad, Street 729
Baghdad Iraq 10045 +964 770 352 0314 alaaj@conursing.uobaghdad.edu.iq University of Baghdad/college of Nursing Iraq Adult patient with undergoing bone marrow aspiration and biopsy local anesthetic, having no experience of bone marrow aspiration and biopsy Full consciousness No hearing and vision impairments based on the patient’s report. 18 years 70 years Both The patient’s withdrawal at any stage of the study Not using a VR headset during bone marrow aspiration and biopsy Developing clinical instability during the procedure (such as loss of conscious- ness, cardiac and respiratory disorders, nausea, oculomotor issues). G89 F06.4 Z01.3 R00.0 R00.1 R06 Pain, not elsewhere classified Anxiety disorder due to known physiological condition Encounter for examination of blood pressure Tachycardia, unspecified Bradycardia, unspecified Abnormalities of breathing Treatment - Other Treatment - Other Treatment - Other N/A Intervention group (A): virtual reality (VR) technology only, this group received virtual reality technology using Samsung gear VR The patient is placed in the prone position and the virtual reality goggles are placed on the patient's head before the bone marrow aspiration and biopsy procedure begins, where a video containing natural scenes is shown through the VR glosses and calm music. After the procedure is completed, the patient's pain are measure by visual analog scale, anxiety are measure by stat-trait anxiety scale (STAS) The 20-item SAI and vital signs are measure by portable monitor device. Intervention group (B): The ShotBlocker is a diminutive, flat, U-shaped plastic apparatus adorned with rounded protuberances. It is applied to the skin during the administration of injections and operates by stimulating the nerve endings situated around the injection site. This tactile stimulation is posited to alleviate pain by temporarily obstructing the conveyance of pain signals to the central nervous system. ShotBlocker put on site of needle insertion of bone marrow aspiration device. After the procedure is completed, the patient's pain are measure by visual analog scale, anxiety are measure by stat-trait anxiety scale (STAS) The 20-item SAI and vital signs are measure by portable monitor device. Intervention group (AB): virtual reality technology and ShotBlocker maneuver use during procedure and After the procedure is completed, the patient's pain are measure by visual analog scale, anxiety are measure by stat-trait anxiety scale (STAS) The 20-item SAI and vital signs are measure by portable monitor device. Control group (C): Subjects in the control group with bone marrow aspiration and biopsy. No intervention was provided during the study. . After the procedure is completed, the patient's pain are measure by visual analog scale, anxiety are measure by stat-trait anxiety scale (STAS) The 20-item SAI and vital signs are measure by portable monitor device Anxiety. Timepoint: Five minutes before bone marrow aspiration - immediately after bone marrow aspiration. Method of measurement: stat-trait anxiety scale (STAS). Changes in vital signs. Timepoint: Five minutes before bone marrow aspiration - during bone marrow aspiration - 5 minutes after bone marrow aspiration. Method of measurement: Portable monitor device. Pain. Timepoint: Immediately after bone marrow aspiration and biopsy. Method of measurement: Visual analog scale (VAS) The VAS is a reliable, valid, responsive, and frequently used pain outcome measure. It consists of a bidirectional 10 cm straight line with two labels, that is, “no pain” and “worst possible pain”, located at either end of the line. Patients are instructed to draw a vertical mark on the line indicating their pain level The reliability data are VAS, (0.97). whereas (0) means no pain, the closer you are to number (10) means sever pain. Anxiety. Timepoint: Immediately after bone marrow aspiration and biopsy. Method of measurement: Stat-trait anxiety scale (STAS) The 20-item SAI and the 20-item Trait Anxiety Inventory are independent of each other. In SAI, each item is scored in four-point Likert-type responses as follows: none: 1, a little: 2, a lot: 3, and completely: 4. In the Trait Anxiety Inventory, each item is scored in four-point Likert-type responses: rarely: 1, sometimes: 2, most of the time: 3, and almost always: 4. Higher scores indicate a higher level of anxiety, whereas low scores indicate that the anxiety level is low. In this study, Cronbach’s alpha value of the state anxiety inventory was found to be 0.937. Vital signs (HR, BP, RR and SPo2) during procedure. Timepoint: Immediately after bone marrow aspiration and biopsy. Method of measurement: Portable monitor device: Vital signs are measured during and immediate after bone marrow aspiration and biopsy ( Patient's device manufacturer: Comen Magic Country: India Model: C86 Serial Number Kf200723063f). The authors of the trial are the funding source Approved 2024-11-06 Research Ethical Approval Committee, at the College of Nursing Bab AL-Muadum Baghdad Alrusafa Iraq